Phase 4
N=1,077
Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
Skin/Soft Tissue Infections · Methicillin Resistant Staphylococcus Aureus (MRSA)
Bottom Line
View on ClinicalTrials.gov: NCT00087490 ↗Enrolled (actual)
1,077
Serious AEs
6.0%
Results posted
Aug 2012
Primary outcome: Primary: Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population — 84.1; 79.9; 15.9; 20.1 Percentage of participants — p=0.249
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- linezolid (Drug); vancomycin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population |
84.1; 79.9; 15.9; 20.1 | 0.249 |
| SECONDARY Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population |
91.6; 87.7; 8.4; 12.3 | 0.168 |
| SECONDARY Clinical Outcome in Participants With Baseline MRSA at EOS for Modified-Intent to Treat (mITT) Population |
80.8; 73.7; 19.2; 26.3 | 0.048 sig |
| SECONDARY Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population |
89.4; 84.7; 10.6; 15.3 | 0.090 |
| SECONDARY Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population |
75.0; 68.4; 25.0; 31.6 | 0.127 |
| SECONDARY Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population |
85.4; 68.8; 14.6; 31.2 | 0.000 sig |
| SECONDARY Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population |
73.5; 65.8; 26.5; 34.2 | 0.051 |
| SECONDARY Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population |
84.2; 69.2; 15.8; 30.8 | 0.000 sig |
| SECONDARY Number of Participants With Clinical Signs and Symptoms at EOT and EOS for PP Population |
21; 17; 1; 5; 0; 3 | — |
| SECONDARY Number of Participants With Clinical Signs and Symptoms at EOT and EOS for mITT Population |
27; 25; 3; 9; 0; 3 | — |
| SECONDARY Duration of Hospital Stay for PP Population |
7.6; 8.9 | 0.022 sig |
| SECONDARY Duration of Hospital Stay for mITT Population |
7.7; 8.9 | 0.016 sig |
| SECONDARY Duration of Intravenous Therapy for PP Population |
5.6; 10.4 | 0.000 sig |
| SECONDARY Duration of Intravenous Therapy for mITT Population |
5.3; 9.8 | 0.000 sig |
| SECONDARY Number of Participants Using Medical Resources |
— | — |
Summary
To determine if linezolid is superior to vancomycin in the treatment of complicated skin and soft tissue infections due to MRSA in adult subjects
Eligibility Criteria
Inclusion Criteria
- Male and female subjects with signs or symptoms consistent with infection, and if available, laboratory findings consistent with staphylococcal infection (e.g., Gram stain and culture results).
- Signs and symptoms consistent with infection
- Infection suspected to be due to Methicillin Resistant Staphylococcus Aureus
Exclusion Criteria
- Subjects who were treated with a previous antibiotic (systemic or topical) with MRSA activity (other than linezolid or vancomycin) for more than 24 hours and treatment extended into the 72 hour period prior to the first dose of study drug, unless documented to be a treatment failure (72 hours of treatment and not responding).
- Subjects with uncomplicated skin or superficial skin structure infection such as superficial/simple cellulitis, impetiginous lesion, furuncle, or simple abscess that only need surgical drainage for cure.
- Subjects excluded with necrotizing fasciitis, gas gangrene, osteomyelitis
Data sourced from ClinicalTrials.gov (NCT00087490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.